Phase 1 Trial of the Combination of Perifosine and Gemcitabine

Trial Information

Phase 1 Trial of the Combination of Perifosine and Gemcitabine

This is a phase 1, open-label trial of perifosine and gemcitabine in patients with
malignancies for whom single agent gemcitabine is a reasonable treatment option. All
patients will receive gemcitabine at a dose of 1000 mg/m2 on days 1 and 8 of a 21-day cycle.
Patients will receive perifosine orally at a dose of 50, 100 or 150 mg per day for the
first 14 days of the 21-day cycle. Cohorts of 3 patients will be treated with doses of 50
mg administered either once, twice or three times a day. In this study a maximum tolerated
dose (MTD) will be defined as a dose that can be given without grade 3/4 non-hematologic
toxicity in more than 1/3 patients. If 2/3 patients in any cohort encounter a grade 3/4
non-hematologic toxicity, an additional 3 patients will be added. If the dose is
intolerable for >3/6 patients then the previous level will be declared the MTD. Once an MTD
has been determined an additional 10 patients will be added at the MTD to better define the
expected toxicities.

Inclusion Criteria

Inclusion Criteria

- Patients must have histologically or cytologically confirmed diagnosis of cancer for
which treatment with single agent gemcitabine would be an appropriate treatment
option

- At least 18 years of age

- Patients may have received no more than two prior chemotherapy regimens

- Patients must have a life expectancy of more than 3 months.

- Patients must have a performance status of 0 to 2 according to the ECOG criteria

- Patients must have normal organ and marrow function as defined in the protocol.

- Patients must have recovered from any acute toxicity related to prior therapy,
including surgery or radiotherapy.

- Patients must be able to ingest oral medications.

- Female patients who are pregnant or lactating are ineligible. All females of
childbearing potential must have a negative serum pregnancy test within 72 hours of
treatment. Men and women of childbearing potential must agree to employ adequate
contraception.

- Patients must have ability to understand and the willingness to sign a written
informed consent document.

Exclusion Criteria

- Patients may not be receiving any other investigational agents or devices.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to perifosine (miltefosine or edelfosine).

- HIV-positive patients receiving combination anti-retroviral therapy are excluded from
the study because of possible pharmacokinetic interactions with perifosine.
HIV-positive patients not receiving combination anti-retroviral therapy must be
approved by the study chair prior to entry.

- Patients with a history of unstable or newly diagnosed angina pectoris, recent
myocardial infarction (within 6 months of enrollment) or New York Heart Assoc. class
II-IV congestive heart failure.

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